Section 150K(1) in The Drugs and Cosmetics Rules, 1945
(1)The approving authority may, after giving the approved institution an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, withdraw an approval granted under this Part or suspend it for such period as he thinks fit either wholly or in respect of some of the categories of drugs or items of cosmetics to which it relates, if in his opinion the approved institution had failed to comply with any of the conditions of the approval or with any provision of the Act or the rules made thereunder.